A Randomized, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients with Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)
A phase 2 Study of RO5137382 (GC33) in Patients With Advanced or Metastatic Hepatocellular Carcinoma
version:
date:
Chugai Pharmaceutical Co., Ltd.
clinical-trials@chugai-pharm.co.jp
Chugai Pharmaceutical Co., Ltd.
clinical-trials@chugai-pharm.co.jp
185
Interventional
Randomized, Double-Blind Study
2
- Adult patients, >/= 18 years of age
- Histologically confirmed hepatocellular carcinoma (without fibro-lamellar subtype)
- Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or documented adverse event(s) associated with prior systemic agent(s) that resulted in discontinuance of that (those) agent(s)
- Not a candidate for curative treatments (e.g. resection, transplantation)
- Child-Pugh A (score of 5-6)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematologic, hepatic and renal function
- Ability to provide, for central review, a tumor tissue sample to determine the level of GPC-3 expression by IHC
- Measurable disease by RECIST 1.1
- Child Pugh B or C
- Known hepatocellular carcinoma with fibro-lamellar histology
- Known brain or leptomeningeal metastases
- Active infectious diseases requiring treatment except for hepatitis B and C
- History of organ allograft including liver transplant
- Anticipated or ongoing administration of anticancer therapies other than those administered in this study
- Anticancer treatment within 2 weeks prior to entering the study
- Patients who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies
- Patients receiving interferon therapy
- Pregnant or lactating women
- Known HIV positivity or AIDS-related illness
- History of hypersensitivity to similar agents (monoclonal antibody, protein-included drugs, Chinese hamster ovary products)
18age old over
No limit
Both
Liver Cancer
investigational material(s)
Generic name etc : GC33 (RO5137382)
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 1600 mg iv Day 1 and 8, and every 2 weeks thereafter
control material(s)
Generic name etc : GC33 (RO5137382) Placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : iv Days 1 and 8, and every 2 weeks thereafter
Progression-free survival
tumor assessments according to RECIST criteria
- Overall survival
- Time to progression (TTP)
- Disease control rate (DCR)
- Safety
- Pharmacokinetics
- GPC-3 expression in tumor tissue (biopsy) by immunohistochemistry (IHC) assay
CTCAE V4.0,IHC
